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CORAL: Cancer of the OvaRy Abiraterone triaL
ISRCTN ISRCTN63407050
DOI 10.1186/ISRCTN63407050
ClinicalTrials.gov identifier
EudraCT number 2013-000293-29
Public title CORAL: Cancer of the OvaRy Abiraterone triaL
Scientific title A phase II study of abiraterone in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer
Acronym CORAL
Serial number at source ICR-CTSU/2012/10038
Study hypothesis The study hypothesis is that abiraterone will show clinical activity in patients with epithelial ovarian cancer (EOC).

We also aim to identify biomarkers of abiraterone sensitivity in EOC and evaluate the molecular impact of abiraterone.
Lay summary Lay summary under review with external organisation
Ethics approval Not provided at time of registration
Study design Prospective open-label non-randomised two-stage phase II clinical trial
Countries of recruitment United Kingdom
Disease/condition/study domain Patients with epithelial ovarian cancer (including fallopian tube and primary peritoneal) that has relapsed within 12 months of last treatment.
Participants - inclusion criteria 1. Histologically or cytologically confirmed epithelial ovarian, fallopian tube (FT) or primary peritoneal (PP) cancer and have progressed (radiological or CA125 criteria) within 12 months of last systemic anti-cancer therapy
2. Life expectancy of at least 12 weeks
3. Post-menopausal defined as:
3.1. Aged ≥ 18 years having had bilateral salpingo-oophorectomy (BSO)
3.2. Aged ≥ 45 years with intact uterus and amenorrhoeic for at least 12 months
3.3. FSH >40 U/L in patients who have had a hysterectomy and ovaries are intact (i.e. not had bilateral oophorectomy)
Documented evidence is required for patients who have undergone irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy
4. ECOG performance status of 0-2
5. No prior hormone therapy (e.g. tamoxifen, aromatase inhibitor, progestogens, anti-androgens)
6. At least one line of prior platinum-based chemotherapy
7. Measurable or evaluable disease (if not measurable by RECIST v1.1 criteria, patients must be evaluable by GCIG CA125 criteria). See Appendix 2
8. Archival primary tumour tissue (FFPE or 8-10 unstained slides) must be available. Otherwise, a biopsy must be carried out to obtain sufficient tissue for histological assessment
9. No evidence of pre-existing uncontrolled hypertension as documented by two baseline blood pressure readings taken at least an hour apart. The baseline systolic blood pressure readings must be <160 and the baseline diastolic blood pressure readings must be <95 mmHg. Patients whose hypertension is controlled by antihypertensive therapies are eligible
10. Haematological and biochemical indices within acceptable specifed ranges
11. Aged 18 years or over
12. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
Participants - exclusion criteria 1. Tumours of mucinous, clear cell, malignant mixed mesodermal (MMMT) or non-epithelial ovarian cancers (e.g. Brenner tumours, Sex-cord tumours)
2. Radiotherapy (except for palliative reasons) or chemotherapy within the preceding three weeks (four weeks for investigational agent or within five half-lives of the investigational agent, whichever is longer)
3. Persistent grade 2 or greater toxicities from any cause except for alopecia or grade 2 peripheral neuropathy
4. Known leptomeningeal involvement or brain metastases
5. Clinical and/or biochemical evidence of hyperaldosteronism or hypopituitarism
6. Unresolved bowel obstruction
7. Major surgery within four weeks prior to entry to the study or minor surgery within two weeks of entry into the study and from which the patient has not yet recovered
8. Treatment with warfarin. Patients on warfarin for DVT/PE can be converted to LMWH at least one week prior to commencement of trial treatment
9. At high medical risk, as deemed by the Principal Investigator, because of non-malignant systemic disease including active uncontrolled infection
10. Known to be serologically positive for hepatitis B and/or hepatitis C
11. Active or uncontrolled autoimmune disease that may require corticosteroid therapy
12. History of clinically significant heart disease, e.g. myocardial infarction or arterial thrombotic event within six months, severe or unstable angina, or New York Heart Association Class III or IV heart disease
13. Systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm Hg documented on at least two different occasions
[Note: Hypertension controlled by antihypertensive therapy is permitted].
14. Any other active malignancy requiring treatment/or whose prognosis will prevent readout from trial endpoints
15. Patients for whom treatment with prednisone or prednisolone is contraindicated
16. Patients participating in or planning to participate in another interventional clinical trial. Participation in an observational trial is acceptable
17. Any other condition which, in the Investigator’s opinion, would not make the patient a good candidate for the clinical trial
Anticipated start date 15/07/2013
Anticipated end date 14/07/2016
Status of trial Ongoing
Patient information material Please use the contact information provided to request a Patient Information Sheet.
Target number of participants 47
Interventions Evaluating the efficacy of abiraterone in patients with ovarian, including fallopian tube and primary peritoneal, cancer.
Oral abiraterone 1000mg (4x250mg) plus 5mg prednisone/prednisolone once a day
Patients will continue on trial treatment until disease progression. We anticipate the study running for around 3 years, from first patient recruited to last patient last data capture

Details of co-sponsor:
Royal Marsden NHS Foundation Trust
R&D Office
Royal Marsden Hospital
Downs Road
Sutton
United Kingdom
Primary outcome measure(s) The primary objective of this study is to determine whether abiraterone has clinical activity (objective response rate assessed by imaging and/or CA125 tumour marker changes in the blood) in patients with epithelial ovarian cancer.
Secondary outcome measure(s) 1. The proportion of patients with objective response according to RECIST
2. The proportion of patients with objective response according to GCIG (CA125)
3. Clinical benefit rate according to RECIST/GCIG criteria at 12 weeks
4. Progression Free Survival (PFS)
5. 6-month PFS
6. Time to Progression (TTP)
7. Overall survival (OS)
8. Toxicity according to CTCAE version 4.0
We will also explore the molecular impact of abiraterone and attempt to identify biomarkers of abiraterone sensitivity in epithelial ovarian cancer.
Sources of funding Study drug and funding provided by Janssen-Cilag.
CORAL has received endorsement from Cancer Research UK (CRUK) (ref: A16037)
Trial website
Publications
Contact name Dr  Susana  Banerjee
  Address The Royal Marsden NHS Foundation Trust
Gynaecology Unit
Downs Road
Sutton
  City/town London
  Zip/Postcode SM2 5PT
  Country United Kingdom
  Email coral-icrctsu@icr.ac.uk
Sponsor The Institute of Cancer Research (UK)
  Address 123 Old Brompton Road
  City/town London
  Zip/Postcode SW7 3RP
  Country United Kingdom
  Sponsor website: http://www.icr.ac.uk/
Date applied 03/04/2013
Last edited 19/09/2014
Date ISRCTN assigned 24/05/2013
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